Label: AVERR AGLOW PURE PROTECTION INVISIBLE MINERAL SUNSCREEN BROAD SPECTRUM SPF 30- zinc oxide and titanium dioxide lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 81664-001-01 - Packager: Averr Aglow LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated March 22, 2021
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Active Ingredient[s]
- Purpose
- Uses
- Warnings
- Warnings
- Warnings
- Warnings
- Warnings
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Directions
- Shake well before use
- Apply liberally and evenly 15 minutes before sun exposure
- Reapply at least every 2 hours
- Use water-resistant sunscreen if swimming or sweating
- Sun Protection Measures: spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including:
- limiting time in the sun, especially from 10 a.m. - 2 p.m.
- wearing long-sleeve shirts, pants, hats, and sunglasses
- children under 6 months: Ask a doctor
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Inactive Ingredients
Deionized Water (Aqua), Caprylic/Capric Triglyceride (RSPO Palm Kernel Derived), Polyglyceryl-6 Stearate (Vegetable Derived), Glycerin (Organic), Corn Starch Modified (non-GMO), Methylpropanediol, Caryodendron Orinocense (Kahai) Seed Oil, Shea Butter Ethyl Esters, Tocopherol (Vitamin E), Niacinamide, Sodium Hyaluronate, Astrocaryum (Tucuma) Seed Butter, Tremella Fuciformis Polysaccharide, Bisabolol, Hippophae Rhamnoides (Sea Buckthorn) Oil, Punica Granatum (Pomegranate) Seed Oil, Pentylene Glycol (Vegetable Derived), Polyhydroxystearic Acid, Polyglyceryl-6 Behenate (Vegetable Derived), Alumina, Rubus Idaeus (Raspberry) Seed Oil, Stearic Acid, Vitis Vinifera (Grape) Seed Oil, Isostearic Acid, Polyglyceryl-3 Polyricinoleate (Vegetable Derived), Caprylyl Glycol, Lecithin, Phenylpropanol, Hydroxyethylcellulose
- Other Information
- Questions or Comments?
- Averr Aglow Pure Protection Invisible Mineral Sunscreen Broad Spectrum SPF 30
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INGREDIENTS AND APPEARANCE
AVERR AGLOW PURE PROTECTION INVISIBLE MINERAL SUNSCREEN BROAD SPECTRUM SPF 30
zinc oxide and titanium dioxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:81664-001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 166.5 mg in 1 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 26.64 mg in 1 mL Inactive Ingredients Ingredient Name Strength NIACINAMIDE (UNII: 25X51I8RD4) HYALURONATE SODIUM (UNII: YSE9PPT4TH) CAPRYLIC/CAPRIC MONO/DI-GLYCERIDES (UNII: U72Q2I8C85) ISOSTEARIC ACID (UNII: X33R8U0062) STEARIC ACID (UNII: 4ELV7Z65AP) LECITHIN, SUNFLOWER (UNII: 834K0WOS5G) TOCOPHEROL (UNII: R0ZB2556P8) POMEGRANATE SEED OIL (UNII: 0UI45XV0T6) SHEA BUTTER ETHYL ESTERS (UNII: V2CI786FPG) ASTROCARYUM VULGARE KERNEL OIL (UNII: 1IQY04O559) POLYGLYCERYL-6 STEARATE (UNII: ETY9Q81E2T) POLYGLYCERYL-6 BEHENATE (UNII: 4T2L7QI313) CAPRYLYL GLYCOL (UNII: 00YIU5438U) .ALPHA.-BISABOLOL, (+)- (UNII: 105S6I733Z) WATER (UNII: 059QF0KO0R) PENTYLENE GLYCOL (UNII: 50C1307PZG) HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D) CARYODENDRON ORINOCENSE WHOLE (UNII: J2T2D81BHU) GLYCERIN (UNII: PDC6A3C0OX) TREMELLA FUCIFORMIS WHOLE (UNII: 4938BNS0GU) METHYLPROPANEDIOL (UNII: N8F53B3R4R) HIPPOPHAE RHAMNOIDES WHOLE (UNII: YAA7TG74X6) GRAPE SEED OIL (UNII: 930MLC8XGG) RASPBERRY SEED OIL (UNII: 9S8867952A) PHENYLPROPANOL (UNII: 0F897O3O4M) MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE) (UNII: 461P5CJN6T) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) Product Characteristics Color Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:81664-001-01 1 in 1 CARTON 05/14/2021 1 50 mL in 1 TUBE; Type 0: Not a Combination Product 
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 05/14/2021 Labeler - Averr Aglow LLC (959806535)
